The Complete Guide ToDirect-to-PatientClinical Trials

What is Direct-to-Patient?

DtP, or Direct-to-Patient clinical trials, are a type of decentralized clinical trial (DCT) where aspects of the trial are conducted at locations outside of the investigator site (e.g., patient’s home, work place, travel destination) and may be executed through the use of mobile/local healthcare providers, wearable/sensor devices, telemedicine, eConsent, etc. DCTs may involve any phase, and most have at least 1 investigator with a physical location.

The main benefits of DtP are to improve enrollment and ease the burden on patients to access trial sites. While the concept of DtP is not new, clinical trial models and supporting infrastructure need to shift.

Three Types of DtP Models

There are three types of DtP Models: Depot-to-Patient, Site-to-Patient and Hybrid.

Depot-to-Patient

The IMP is shipped directly from the main or sub depot (e.g. central pharmacy)

to the patient home. Nurse services may be added.

Site-to-Patient

The IMP is shipped from the depot to the site, and from the site to the patient home.

Hybrid

A mix of DtP/traditional site visits. In other words, when patients have site visit(s) and also

receive IMP at the home (from depot or other site) in other visits.

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Direct-to-Patient Clinical Trials

Learn more about the differences between the models and which type of studies benefit most from DtP.

RTSM systems play a critical role in ensuring the right medication gets to the right patient at the right time. Leveraging an RTSM can enable DtP trials, effectively mitigating the supply chain risks mentioned above and ensure the integrity of a DtP trial. The use of an RTSM dramatically reduces the risk of shipment coordination. Shipments can be generated automatically or manually and the forecasting algorithm can manage different methods of shipping. Inventory can be managed on all levels.

With 100% configurability, sponsors can choose from the following DtP capabilities. These can be switched on or off at any time, pre or post go-live, depending on the study needs:

• Any DtP model or combination thereof at the patient, study, site, visit and country level. (This is especially critical when adhering to different rules and regulations across the globe.)

• DtP set for certain periods of time

•DtP for all or just selected patients

• DtP for all or just selected visits

• DtP for all or just selected sites

SEE FOR YOURSELF

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Prancer RTSM™ offers never before seen DtP functionality to enable sponsors to choose the model that best fits their study needs. Let us show you how you can start leveraging DtP in your studies today.

In the midst of this outbreak, there are countless immunocompromised individuals still traveling to clinical sites to participate in trials to receive critical and sometimes life-saving treatments. See first-hand how the novel coronavirus is impacting clinical trial participants and research sites alike.

Stephanie AbbottPharmacist & Clinical Research Director, Western Washington Medical Group

SCRS Podcast Featuring 4G Clinical:

"Sponsors are Transitioning to Direct-to-Patient Trials – Are you Prepared?"

In an effort to ensure clinical trial continuity in the midst of COVID-19, more and more sponsors are moving towards Direct-to-Patient models to ensure patient access to medications. In order for sites to adequately prepare for this new approach, it is imperative to understand current trends and challenges as sponsors are approaching these models differently depending on their study and supply chain considerations.

Is Now the Right Time to Switch to Direct-to-Patient (DtP) Trials?

COVID-19 has rapidly entered the world stage and is changing the course of research. Patients are fearful of going to the investigator site for treatment. Sites are trying to limit unnecessary visits so patients won’t be exposed to the Coronavirus and are encouraging telemedicine and other virtual options. The ability to ship drug directly to the patient rather than requiring them to come to the clinic can protect the health and safety of trial participants.

If you are thinking of moving toward DtP, here are 5 key considerations: